# FRO · Dressing, Wound, Drug

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/FRO

## Overview

- **Product Code:** FRO
- **Device Name:** Dressing, Wound, Drug
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 703)

Showing 20 most recent of 703 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K254073](/device/K254073.md) | StatSeal Disc | Merit Medical Systems, Inc. | May 13, 2026 | SESE |
| [K254191](/device/K254191.md) | IWD-Gel™ | InnovaCorium, Inc. | Apr 7, 2026 | SESE |
| [K252023](/device/K252023.md) | MiraChlor Antimicrobial Wound Solution | Letus Corporation | Mar 25, 2026 | SESE |
| [K251999](/device/K251999.md) | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | Mar 13, 2026 | SESE |
| [K252028](/device/K252028.md) | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | Mar 11, 2026 | SESE |
| [K251582](/device/K251582.md) | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | Feb 2, 2026 | SESE |
| [K252568](/device/K252568.md) | New Day Skin Spray | Silk Holdings, Inc. | Jan 23, 2026 | SESE |
| [K250890](/device/K250890.md) | SBC1 Cream | Sioxmed, LLC | Jan 12, 2026 | SESE |
| [K252759](/device/K252759.md) | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | Jan 8, 2026 | SESE |
| [K251757](/device/K251757.md) | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | Jan 5, 2026 | SESE |
| [K252167](/device/K252167.md) | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | Dec 19, 2025 | SESE |
| [K250642](/device/K250642.md) | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | Nov 19, 2025 | SESE |
| [K250115](/device/K250115.md) | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | Oct 14, 2025 | SESE |
| [K251866](/device/K251866.md) | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | Oct 10, 2025 | SESE |
| [K243166](/device/K243166.md) | Dermalage | Infection Elimination Solutions, LLC | Aug 27, 2025 | SESE |
| [K243415](/device/K243415.md) | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | Jul 22, 2025 | SESE |
| [K251093](/device/K251093.md) | Bonvadis® | Oneness Biotech Co., Ltd. | Jun 9, 2025 | SESE |
| [K243457](/device/K243457.md) | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel | Seriously Clean, Ltd. | May 2, 2025 | SESE |
| [K243875](/device/K243875.md) | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. | Apr 21, 2025 | SESE |
| [K242406](/device/K242406.md) | SiOxC Cream | Sioxmed, LLC | Mar 13, 2025 | SESE |

## Top Applicants

- Huizhou Foryou Medical Devices Co., Ltd. — 16 clearances
- Convatec, A Division of E.R. Squibb & Sons — 13 clearances
- Derma Sciences, Inc. — 12 clearances
- Winner Medical Co., Ltd. — 12 clearances
- 3M Company — 10 clearances

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**Source:** [https://fda.innolitics.com/productcode/FRO](https://fda.innolitics.com/productcode/FRO)

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